Monday, April 24, 2017

Ninth Circuit bars consumer claims challenging assertions of clinical proof

Kwan v. SanMedica Int’l, -- F.3d --, No. 15-15496, 2017 WL 1416483 (9th Cir. Apr. 21, 2017)

Kwan alleged that SanMedica’s product SeroVital was falsely advertised as effective, and the district court dismissed her complaint as a lack of substantiation claim not actionable under California consumer protection law. The court of appeals affirmed.

SanMedica advertised, inter alia, that its product had been clinically tested and shown to produce a 682% increase in human growth hormone (HGH), which had multiple physical and cosmetic benefits.  To proceed in a challenge to this claim, Kwan would apparently need to allege “that one or more of the authorities alluded to actually studied or tested the formula SeroVital contains and found that it does not produce a 682% mean increase in HGH levels, or that Plaintiff herself did not experience such an increase when using the product, or that a study exists somewhere demonstrating that a 682% increase is categorically impossible to achieve in an over-the-counter pill.” Instead, she only alleged that the study relied upon to make the claim was “not an example of scientific evidence recognized by experts, was never peer-reviewed, and was never published in a peer-reviewed journal.”  So even if affirmative statements about the existence of clinical tests proving effectiveness are material to consumers, California law doesn’t allow challenges to those statements merely because the consumer might be able to show that the test didn’t demonstrate the truth of the affirmative statement.

I think this is a mistake—with such evidence, the challenger has shown that the statement about clinical proof is false, even if she hasn’t falsified another part of the ad; the Lanham Act also doesn’t allow mere lack of substantiation claims, but Lanham Act jurisprudence correctly recognizes that there can be separable statements about the proof behind another statement—and advertisers make those statements in order to convince consumers that their statements are credible.


The court of appeals found that it wasn’t enough to allege that the “clinically tested” representation and the health benefit claims falsely implied that the marketing claims of SeroVital’s health benefits were clinically proven by credible scientific proof. That was just a lack of substantiation allegation, repackaged.  The court rejected Kwan’s invocation of Lanham Act establishment claim precedent because doing so “would clearly violate recognized California law on the burden of proof placed on the plaintiff.”  As readers are probably aware, the burden is also on the plaintiff to show falsity under the Lanham Act; the Lanham Act precedent, however, makes clear that statements or implications about proof can themselves be false.  Kwan wasn’t trying to shift the burden of proof, as the court accused her of doing; she was challenging the truth of some of SanMedica’s claims.

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